Code of Federal Regulations Title 21. Food and Drugs § 21.868.2380 Nitric oxide analyzer

(a) Identification. The nitric oxide analyzer is a device intended to measure the concentration of nitric oxide in respiratory gas mixtures during administration of nitric oxide.

(b) Classification. Class II. The special control for this device is FDA's “Guidance Document for Premarket Notification Submissions for Nitric Oxide Administration Apparatus, Nitric Oxide Analyzer, and Nitrogen Dioxide Analyzer.”